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FDA Approval

Pilocarpine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 22, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pilocarpine(40 mg in 1 mL)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pilocarpine Hydrochloride

Product Details

NDC Product Code
60219-1747
Application Number
ANDA214193
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
September 22, 2020
Code: 0WW6D218XJClass: ACTIBQuantity: 40 mg in 1 mL
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Pilocarpine Hydrochloride

Product Details

NDC Product Code
60219-1746
Application Number
ANDA214193
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
September 22, 2020
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958Class: IACT
Code: 0WW6D218XJClass: ACTIBQuantity: 20 mg in 1 mL
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Pilocarpine Hydrochloride

Product Details

NDC Product Code
60219-1745
Application Number
ANDA214193
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
September 22, 2020
Code: 0WW6D218XJClass: ACTIBQuantity: 10 mg in 1 mL
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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Pilocarpine Hydrochloride - FDA Approval | MedPath